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Diss Factsheets
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EC number: 203-184-2 | CAS number: 104-20-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- The test is performed according to OECD criteria.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Minesterium für Umwelt, Klimatschutz, Landwirtschaft und Verbraucherschutz
Test material
- Reference substance name:
- 4-(4-methoxyphenyl)butan-2-one
- EC Number:
- 203-184-2
- EC Name:
- 4-(4-methoxyphenyl)butan-2-one
- Cas Number:
- 104-20-1
- Molecular formula:
- C11H14O2
- IUPAC Name:
- 4-(4-methoxyphenyl)butan-2-one
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: human reconstructed epidermis model
- Details on test animals or test system and environmental conditions:
- Epi-200 SIT kits and MTT-100 assays diluent from MatTek Corporation (82105 Bratislava, Slovakia).
EpiDerm tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of human epidermis
Test system
- Type of coverage:
- other: in vitro test
- Preparation of test site:
- other: in vitro test
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: 30µL DPBS (MatTek) ; Positive control: 30µL of a 5% SLS (Sodium Lauryl Sulphate) solution in deiosined water (MatTek)
- Duration of treatment / exposure:
- 60 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 96.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results:
Dose | Treatment Interval | Absorbance 570 nm Tissue 1* | Absorbance 570 nm Tissue 2* | Absorbance 570 nm Tissue 3* | Mean Absorbance of 3 Tissues | Rel. Absorbance (%) Tissue 1, 2, 3 ** | Relative Standard Deviation | Mean Rel. Absorbance (% of negative control)*** |
Negative Control | 60 min | 1.705 | 1.552 | 1.747 | 1.668 | 102.2 | 6.1 | 100.0 |
93.1 | ||||||||
104.7 | ||||||||
Positive Control | 60 min | 0.075 | 0.083 | 0.085 | 0.081 | 4.5 | 6.4 | 4.9 |
5.0 | ||||||||
5.1 | ||||||||
Test item | 60 min | 1.537 | 1.663 | 1.630 | 1.610 | 92.2 | 4.0 | 96.5 |
99.7 | ||||||||
97.7 |
* Mean of three replicate wells after blank correction
** Relative absorbance per tissues (rounded value): (100*absorbance of tissue)/ (mean absorvbance negative control)
*** Relative absorbance per treatment group (rounded values): (100* mean absorbance (test item/positive control))/(mean absorbance negative control).
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 96.5% (threshold for irritacy ≤ 50%), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported the test substance is not irritant to skin to UN GHS and EU CLP regulation.
- Executive summary:
The study has been performed according to OECD 439 guideline. This in vitro study was performed to assess the irritation properties of the test substance. by means of the Human Skin Model test.
The test item did not reduce MTT and it did not change colour when mixed with deionised water. Consequently, additional tests with freeze-killed or viable tissues were not necessary.
Each three tissues of the human skin model EpiDerm were treated with the test item, the negative control and the positive control for 60 minutes. 30 µL of the test substance were applied to each tissues, and spread to match the surface of the tissues. 30 µL of either the negative (DPBS) or the positive control (5% SLS) were applied to each tissue.
After treatment with the negative control the absorbance values were well in the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for 60 minutes treatment interval, and thus assuring the validity of the test system.
After the treatment with the test substance, the mean relative absorbance value decreased irrelevantly to 96.5% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%.
Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported the test substance is not irritant to skin to UN GHS and EU CLP regulation
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